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Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement

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ClinicalTrials.gov Identifier: NCT01032538
Recruitment Status : Unknown
Verified September 2016 by Tor Kjetil Nerhus, Martina Hansen's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 15, 2009
Results First Posted : January 13, 2015
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Tor Kjetil Nerhus, Martina Hansen's Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osteoarthritis
Enrollment 99
Recruitment Details All recruited from Martina Hansens Hospitals patients
Pre-assignment Details  
Arm/Group Title Patients With Knee Osteoarthritis
Hide Arm/Group Description Patients eglible for unicondylar knee replacement
Period Title: Overall Study
Started 99 [1]
Completed 99 [1]
Not Completed 0
[1]
Knees
Arm/Group Title Patients With Knee Osteoarthritis
Hide Arm/Group Description Patients eglible for medial unicompartmental knee replacement
Overall Number of Baseline Participants 96
Hide Baseline Analysis Population Description
Number of patients were 96. 3 patients were operated bilaterally. Number of knees were therefore 99.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants
<=18 years
0
   0.0%
Between 18 and 65 years
42
  43.8%
>=65 years
54
  56.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants
65  (6.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants
Female
57
  59.4%
Male
39
  40.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 96 participants
96
1.Primary Outcome
Title Knee Injury and Osteoarthritis Outcome Score
Hide Description Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.
Time Frame Preoperative until 2 years postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KOOS Pain 2 Years KOOS ADL 2 Years
Hide Arm/Group Description:
Knee pain score, one of 5 subscores of KOOS
Activities of dayly living score
Overall Number of Participants Analyzed 96 96
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
85.5
(82 to 89)
88.2
(85 to 91)
2.Secondary Outcome
Title Range of Motion
Hide Description [Not Specified]
Time Frame Preoperative until 2 years postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Passive ROM 2 Years
Hide Arm/Group Description:
Range of motion measured by physiotherapist
Overall Number of Participants Analyzed 96
Mean (95% Confidence Interval)
Unit of Measure: degrees
128
(123 to 130)
3.Secondary Outcome
Title Oxford Knee Score
Hide Description [Not Specified]
Time Frame Preoperative until 2 years postoperatively
Outcome Measure Data Not Reported
4.Secondary Outcome
Title UCLA Score
Hide Description [Not Specified]
Time Frame Preoperative until 2 years postoperatively
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Knee Injury and Osteoarthritis Outcome Score
Hide Description [Not Specified]
Time Frame 10 years postoperatively
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Oxford Knee Score
Hide Description [Not Specified]
Time Frame 10 years postoperatively
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description 96 patients with 99 knees included in the study
 
Arm/Group Title Patients With Knee Osteoarthritis
Hide Arm/Group Description Patients eglible for unicompartmental knee replacement
All-Cause Mortality
Patients With Knee Osteoarthritis
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Knee Osteoarthritis
Affected / at Risk (%) # Events
Total   5/96 (5.21%)    
Musculoskeletal and connective tissue disorders   
Revision to total knee arthroplasty   5/96 (5.21%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Knee Osteoarthritis
Affected / at Risk (%) # Events
Total   0/96 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Tor Kjetil Nerhus
Organization: Martina Hansens Hospital
Phone: +47 93409934
Responsible Party: Tor Kjetil Nerhus, Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT01032538     History of Changes
Other Study ID Numbers: TKN-002
19441 (NSD) ( Registry Identifier: Norwegian Privacy Ombudsman for Research )
First Submitted: December 14, 2009
First Posted: December 15, 2009
Results First Submitted: October 25, 2013
Results First Posted: January 13, 2015
Last Update Posted: October 28, 2016